KR101450383B1 - System and method for managing data of clinical trial based on the project activity of the clinical trial center - Google Patents

Abstract

The present invention provides a system capable of effectively managing and inputting and outputting data related to clinical trials. According to the present invention, all information related to clinical trials such as task information, subject information, activity information, schedule information, material information, It can be managed systematically and efficiently, and it is possible to efficiently manage the access right to information related to the subject, which is personal information.

Description

TECHNICAL FIELD The present invention relates to a clinical trial data management system based on task information of a clinical trial center and a method for managing clinical trial data using the same,

The present invention relates to a system for effectively managing and inputting and outputting data related to clinical trials.

Clinical trials are tests that are conducted directly on a person or by using information about a person or person extracted from a person. Therefore, it is common in large-scale medical facilities or specialized clinical trial centers to consider the stability of the test.

Therefore, various clinical trial subjects are inevitably carried out at the same place where the clinical trial is performed, and accordingly, a lot of information such as information on a plurality of subjects, information on a large number of subjects, and information on a plurality of test results are accumulated .

Clinical trials require strict information management because they deal with confidential information such as medicines and procedures that are not available on the market while targeting people. However, many information management systems used on the market do not meet the needs of clinical trial institutions as shown below.

First, most information management systems currently used only take the position of the task owner. As a result, it is difficult to effectively manage vast amounts of information in the context of performing clinical trials.

Second, huge information accumulates exponentially with time, but it is difficult to distribute and manage it efficiently with current information management system.

Third, in case of information related to subjects requiring security, user management setting is indispensable, but there is no system to provide such information.

Specifically, a conventional clinical test information management system will be described as follows.

Korean Patent Publication No. 10-2010-0133663 and Korean Publication No. 10-2011-0066576 disclose a method of handling subject activity information but it is impossible to manage the task as an upper category of the subject, Is not efficient.

Japanese Laid-Open Publication No. 2003-114231 discloses a processing method for detecting a specific pattern of clinical trial information, but does not propose a whole clinical information management method.

SUMMARY OF THE INVENTION The present invention provides a system for efficiently and systematically managing information related to clinical trials.

In particular, there is a problem that the task information, the task activity information, the subject information, the subject activity information, the visit plan of the subject, the visit appointment, and the visit history are separately managed, To do this, each information is mapped according to the connection relationship.

By providing subject information and subject activity information for each subject, information in the database can be easily browsed and modified for each subject, subject and person in charge.

In order to use it conveniently, I want to be able to display a visit plan, appointment, history, etc. in the form of a calendar.

To clarify subject registration goals by task and to facilitate the subject registration status, it should be possible to manage the subject registration plan separately.

It is difficult to track the change status when the basic items of the assignment are changed.

According to an aspect of the present invention, there is provided an information processing apparatus including: an input / output unit; A task information database 110 in which task information 111 input by the input / output unit 310 is stored; A subject database 130 in which the subject information 131 is mapped to the subject information 111 by the input / output unit 310 and stored; A subject activity database (140) in which subject activity information is mapped to the subject information (131) by the input / output unit (310) and stored; And a schedule management module 220 interlocked with the input / output unit 310, the subject database 130, and the subject activity database 140. The task information 111 is information on a clinical trial task , The subject activity information includes subject visit plan information including the visit date and the schedule management module 220 receives the requested clinical trial task (s) through the input / output unit 310, And outputting the subject information 131 mapped to the subject information 111 related to the subject information 111 and outputting the visit date included in the subject person activity information in the form of a calendar according to a predetermined method. Management system.

The clinical trial data management system may further include a task activity database 120 in which task activity information is mapped to the task information 111 by the input / output unit 310 and stored, The schedule management module 220 may include an activity corresponding to the visit date included in the task information 111 and the schedule management module 220 may request the output of the clinical trial task through the input / It is preferable that the daily activity included in the task activity information mapped to the task information 111 related to the received clinical trial task is further output in a calendar form according to a predetermined method.

The scheduling module 220 further includes a scheduling module 300 for scheduling the tasks to be performed by the scheduling module 220 through the input and output unit 310, It is preferable to output the contact information included in the assignment information 111 related to the requested clinical trial task, the activity by date for the contact person information, and the visit date linked to the contact information.
The task activity information preferably includes an agreement acquisition activity for the subject, a screening activity for the subject, and a monitoring activity for the subject.

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Also, the clinical test data management system may further include a quotation management module 210, the task information 111 may further include estimating information, and the quotation management module 210 may include the input / output unit 310 When the output of the clinical trial task is requested, it is preferable to output the estimate information included in the task information 111 related to the requested clinical trial task.
The clinical test data management system further includes a material database 150 in which the material information is stored and the material information is mapped to the task information 111 by the input and output unit 310, ).

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The task information 111 further includes information on the number of target subjects input by the input and output unit 310. The estimate management module 210 receives the input of the clinical trial task through the input / Outputs the target number of subjects information included in the task information 111 related to the requested clinical trial task, or accumulates and outputs the target number of subjects included in the target number information for a predetermined period of time .

Further, the task information 111 further includes information on the number of currently performed subjects inputted by the input / output unit 310, and the quotation management module 210 is configured to receive the clinical trial task The number of currently performed subjects contained in the task information 111 related to the requested clinical trial task is output or the number of currently performed subjects included in the currently performed subject information for a predetermined period is output It is preferable to output them in a cumulative manner.

Further, the task information 111 further includes a task tracking list input by the input / output unit 310, and the quotation management module 210 receives the output of the clinical trial task through the input / Upon request, it is preferable to further output the task tracking list included in the task information 111 related to the requested clinical trial task.

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The clinical test data management system further includes a protocol setting module 230. The quotation management module 210 stores the testee visit date inputted through the input / output unit 310 in the testee activity information, The protocol setting module 230 calculates an error between the visit date of the subject inputted through the input / output unit 310 and the visit date of the subject according to the subject visit plan included in the subject activity information, The schedule management module 220 determines whether the clinical test task is included in the task information 111 related to the requested clinical trial task through the input / output unit 310 It is possible to output in the form of a calendar according to a predetermined method whether or not the visit date of the included subject falls within the error range of the subject visit plan Preferable.

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In addition, the subject activity information includes a subject test appointment date, and the protocol setting module 230 determines whether the subject visit date entered through the input / output unit 310 matches the subject test appointment dates included in the subject activity information Or not.

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According to the present invention, all information related to the clinical test such as task information, subject information, activity information, schedule information, material information, and quotation information can be systematically and efficiently managed, and the authority to access information related to the subject, can do.

In addition, all kinds of activities to be performed by the task execution person are provided as a calendar form, so that the clinical trial can be effectively performed.

In particular, task information, task activity information, subject information, subject activity information, subject's visit plan, visit appointment, and visit history can be managed in an integrated manner.

By providing subject information and subject activity information for each subject, information in the database can be easily browsed and modified for each subject, subject and person in charge, thereby increasing work efficiency.

The subject registration plan can be managed, the subject registration target for each task can be easily created, and the subject registration status can be easily grasped.

It is easy to keep track of the change status when the fundamentals of the task are changed by providing a task tracking list.

1 and 2 are conceptual diagrams for explaining the present invention,
3 to 8 show screens output by the present invention.

Hereinafter, the present invention will be described in detail with reference to the drawings.

Explanation of information

First, referring to FIG. 2, the linkage of information corresponding to the present invention will be described.

The information used in the present invention can largely be divided into task information 111, task activity information, subject information 131, and subject activity information.

The task information 111 may include a task code, a task execution period, a task name, a responsible unit and a person in charge, a quote, a task tracking list, and a subject registration plan information.

Task Tracking list means revision history of task information. If significant items related to the research are changed, such as changes to the plan or consent form, enter the change details. When a task tracking list is added, all change histories for the task can be output to the user through the input / output unit 310, and only the most recently written task information and the most recent data applied up to the latest task tracking list Output.

The subject registration plan information may include the number of target subjects required to perform the task, the number of current subjects to be performed, and may be set so as to accumulate in such a manner that a target value is added for each period set by the user. In addition, the subject information of the subject can be mapped. The mapping may be performed through the input / output unit 310 during the input process.

The subject information 131 is information related to the subject. The most important information among the subject information 131 is what subject is the subject. To this end, the subject information 131 is mapped to the task information 111. The mapping may be performed through the input / output unit 310 during the input process. The subject information 131 may include the subject, name, sex, age, registration date, contact information, and the like.

In the task information 111, task activity information, which is information related to an activity performed in association with the task, is mapped. This mapping can be performed in the integrated input process of the input / output unit 310. [ The assignment activity information includes screening activities such as preliminary preparation work, consent form acquisition activity, medical history investigation, monitoring activities, and task organizing activities.

The task activity information is information on activities by date. For example, it is stored in the form of the date on which consent form acquisition activity is to be performed.

The subject activity information includes information on the subject visit plan (protocol), and the information on the subject visit plan (protocol) includes the visit date, visit plan, and visit appointment date. The visit plan is to input a predetermined visit plan of the subject according to the protocol, and to confirm whether or not the visit was made within the error range suggested within the protocol by inputting the visit date after the actual subject visited. A visit appointment is a schedule that the subject promises to visit.

In addition, the subject activity information may further include a questionnaire, a body detection, an abnormality confirmation, a concurrent medication confirmation, a scan reservation, an activity type performed at the visit of the subject, education, .

That is, the task activity information and the subject information 131 are mapped to the task information 111, and the subject activity information is mapped to the subject information 131. [ This mapping can be performed in the integrated input process of the input / output unit 310. [

For example, as shown in FIG. 2, the task information, which is the comprehensive information of the task, the task activity information necessary for performing the task, and the subject information, which is general information about the subject of the task, The information is mapped to the subject activity information including the subject's visit plan information.

Accordingly, when the system user according to the present invention selects a specific task, comprehensive information related to the task is output, all activities related to the task are output, integrated information related to the subject of the task is output, .

On the other hand, when a predetermined subject is selected, the visit plan of the subject is output, comprehensive information related to the subject is output, and information on what subject the subject performs is displayed together.

On the other hand, since the person in charge is assigned to the task information 111, when a specific person is selected, the task activity to be performed by the person in charge is output, and the subject activity to be performed by the person in charge can be output.

Further, the system according to the present invention separately manages the material information. This information can be used in conjunction with the task information so that the materials needed to perform the task and the materials consumed in performing the task can be integrally managed.

Description of system components

The system according to the present invention includes a database unit, a module unit, and an input / output unit 310.

The database section includes a task information database 110, an assignment activity database 120, a subject database 130, a subject activity database 140, and a material database 150. The databases are interlocked around the task information database 110.

More specifically, the task information 111 is stored in the task information database 110, and includes basic information of the task, a task tracking list, and subject registration plan information.

The task activity database 120 includes the task activity information, which is related to general activities according to the above-described tasks in the description field of the information.

The subject database 130 includes the subject information 131, which includes the subject's basic information.

The subject activity activity database 140 includes the subject activity information, which includes activities for the subject individual, subject visit plan (protocol), visit appointment, and the like as described above in the description field of the information.

The module unit includes a quotation management module 210, a schedule management module 220, a protocol setting module 230, a master page processing module 240, a material management module 250, a statistical processing module 320, (330).

The quotation management module 210 can manage the estimates of the tasks in association with the task information database 110, the task activity database 120, the subject database, the subject activity database, and the material database.

More specifically, it is as follows. The quotation management module 210 accesses the task information database 110, inputs basic information of the task, inputs and confirms a tracking list with respect to the task change, plans the subject registration of the task, and confirms the performance .

The assignment tracking list confirmation can view all the change history of the assignment according to the user's selection or only the assignment history reflecting the initial input data and the most recent assignment tracking list.

Confirmation of the subjects' registration achievement of the task can confirm the number of the target subjects and the number of subjects who are performing the task according to the specific period. It can also be confirmed as an accumulation value according to a specific period. For example, the number of target subjects and the number of subjects required to perform the task on a monthly basis can be confirmed or confirmed as a monthly cumulative number. The numerical value may be expressed in a graph by a statistical processing module to be described later.

In addition, the quotation management module 210 may access the assignment activity database 120 to input activities performed in relation to the assignment activities and tasks performed on the subjects before the registration of the users, assign the activities previously entered in the assignment, You can view the history of the assignment activity and modify and delete the changes that need to be made.

In addition, the quotation management module 210 can access the subject database 130 to register the subject and input subject basic information.

The quotation management module 210 may also access the subject activity database 140 to enter the subject activity to the selected subject. You can also enter and modify subject visit plans (protocols), visit history, and appointment appointments.

Specifically, the visit plan (protocol) is input in a periodically repeated form for a specific period and may have an error range. For example, a visit plan can be set at 7-day intervals for 12 weeks from the selected day. If the error range is set at 3, the visit plan will have a visit day for 3 days before and after the creation date.

The visit history is the actual visit of the subject according to the visit plan of the subject. For example, the user selects a planned date on the calendar through the input / output unit 310, which is transmitted to the quotation management module 210, and the quotation management module 210 transmits the date of actual visit to the subject activity of the subject activity database 140 You can enter the information as a new visit and save it.

A visit appointment is a schedule that the subject promises to visit for each task, and can store the date the subject promises to visit in the subject activity database. If you have other history to save together, you can save it after inputting other details in the memo field.

The protocol setting module 230 interlocks with the subject activity database 140 to process a visit of a specific subject and calculation of a visit appointment. (Protocol) information stored in the subject activity database 140 and the visit history information so as to determine whether the subject visited the subject within the error range of the visit plan day by the calculation process of the visit plan, If it matches a plan (protocol), it indicates that it is consistent with the plan; otherwise, it indicates that it is inconsistent with the plan. This can be displayed on the calendar as an example. Fig. 7 shows a plan to be visited. The icon indicating that the subject's visiting plan is shown in FIG. 7 is an icon indicating that the subject's visit history exists in the visiting plan, and that the error range is calculated on the visiting planning day or the visiting planning day, If there is no visit to the subject within the error range of the subject visit plan while the last day is over, the icon is changed to an icon indicating inconsistency with the plan.

Also, whether the subject is well following the visit plan for the subject can be calculated as a percentage of the visit history conformity according to each plan, stored in the subject activity database 140, and displayed to the user through the input / output unit 310 .

By processing the visit appointment, the data on whether the subject visited during the visit appointment day can be processed to calculate whether the visit appointment is consistent with the visit appointment and whether the visit appointment for the subject is cumulatively implemented It can be stored in the subject activity database 140 and can be displayed to the user through the input / output unit 310.

The schedule management module 220 manages information related to the date among the subject activities and task activities such as the subject visit plan. For example, the task activity and the subject activities to be performed on a specific day can be informed to the user, and the information can be displayed more effectively by outputting it in a calendar form through the input / output unit 31. For example, a visit plan is shown in Fig. 7, and a visit appointment is shown in Fig.

The master page processing module 240 can manage the contents of the database on the basis of the task by interlocking with the task information database 110, the task activity database 120, the subject information database 130, and the subject activity database 140 .

The user searches for the task management, quotation, actual cost, billing history, visit history, subject registration, subject registration status, and the like stored in the databases and arranges them on the basis of the tasks and displays them to the user through the input / output unit 310, The user can operate the master page through the database 310 to access the database and manipulate the information.

The material management module 250 interlocks with the material database 150 to check the variation of the material information.

The statistical processing module 320 can statistically process data related to subject registration. For example, it is possible to graph and output monthly registration results and accumulated registration results.

The user authority setting module 330 is for protecting the subject information. The user can set the access right for the subject database 130 and the subject activity database 140 by setting the authority for each user using a conventionally known method have.

Explanation of how to use the system

1. Registration of tasks and registration of task activities

Fig. 3 shows the task registration screen, and Fig. 4 shows the task activity registration screen.

The user can create task information through the quotation management module 210 using the input / output unit 310 and create a task tracking list for modifying the task information. The task tracking list can be viewed entirely, or only partially. In addition, subject registration plan information and subject registration results can be created. These are stored in the task information database 110. Also, the task activity necessary for performing the task is input to the estimate activity management module 210 using the input / output unit 310 together with the date, which is stored in the task activity database 120 by the estimate management module 210.

Basic task activity information necessary for the clinical test can be input in advance and provided to the user as an initial value. Fig. 5 shows assignment activity information provided basically.

2. Registration of subject and registration of subject activity

The user selects an assignment through the quotation management module 210 using the input / output unit 310, registers the subject of the assignment, and stores it in the subject database 130 by the quotation management module 210. In addition, the input and output unit 310 is used to input the test subject activity required for the test execution of the subject through the quotation management module 210, together with the date, and the test subject activity activity is stored in the subject activity database 140.

Basic subject activity information necessary for the clinical test can be input in advance and provided to the user as an initial value. FIG. 6 shows assignment activity information provided basically.

Also, the user can set the subject visit plan through the quotation management module 210 using the input / output unit 310, and input the visit details and the visit appointment. These are stored in the subject activity database 140 by the quotation management module 210. Fig. 7 shows a screen for registering the subject visit plan.

3. Schedule Management

The clinical trial data management system processes the information on the visit plan and visit appointment of a specific subject stored in the subject activity database 140 via the protocol setting module 230.

The protocol setting module 230 compares the visiting schedule information (protocol) information stored in the subject activity database 140 with the visiting history information and confirms whether the visit date of the subject matches the subject visiting schedule (protocol). That is, the error of the comparison result can be calculated. Further, since the error range is set in advance, it can be confirmed whether the calculated error deviates from the error range.

Also, whether the subject is well following the visit plan for the subject can be calculated as a percentage of the visit history conformity according to each plan, stored in the subject activity database 140, and displayed to the user through the input / output unit 310 .

In addition, the protocol setting module 230 judges whether the subject visited the appointment day by relating the subject appointment information and the visit history information stored in the subject activity database 140, and determines whether the subject has visited the appointment for the subject And can store it in the subject activity database 140 and display it to the user through the input / output unit 310. [

The user manipulates the schedule management module 220 by using the input / output unit 310 to display a task, task activity information, subject information, subject activity information, subject visit plan progress and result of the visit plan, You can see the results in a calendar format. Is output as a calendar form as shown in Fig. 8, in which the subject and the subject (indicated in parentheses in the drawing) are output together.

4. Use of master page processing module 240

A task activity database 120, a subject information database 130, and a subject activity database 140 for each task by operating a master page through a master page processing module using the input / output unit 310. [ Lt; / RTI >

It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Therefore, the technical scope of the present invention should not be limited to the contents described in the detailed description of the specification, but should be defined by the claims.

110: task information database
120: Assignment activity database
130: Subject database
140: subject activity database
150: Material database
210: quotation management module
220: Schedule management module
230: Protocol setting module
240: master page processing module
250: Material management module
310: Input /
320: Statistics processing module
330: User Authorization Module

Claims (17)

An input / output unit 310;
A task information database 110 in which task information 111 input by the input / output unit 310 is stored;
A subject database 130 in which the subject information 131 is mapped to the subject information 111 by the input / output unit 310 and stored;
A subject activity database (140) in which subject activity information is mapped to the subject information (131) by the input / output unit (310) and stored;
A schedule management module 220 interlocked with the input / output unit 310, the subject database 130, and the subject activity database 140; And
And a quotation management module 210 interlocked with the input / output unit 310,
The task information 111 is information on a clinical trial task,
The task information 111 further includes estimating information,
The subject activity information includes subject visit plan information including the visit date, and
The schedule management module 220 outputs the subject information 131 mapped to the task information 111 related to the requested clinical trial task through the input and output unit 310 when requesting the output of the clinical trial task And outputs the visit date included in the subject activity information in the form of a calendar according to a predetermined method,
The quote management module 210 may output the quote information included in the assignment information 111 related to the requested clinical trial task when the output of the clinical trial task is requested through the input / output unit 310 ≪ / RTI >
Clinical trial data management system.
The method according to claim 1,
The clinical test data management system further includes a task activity database 120 in which task activity information is mapped and input to the task information 111 by the input / output unit 310,
The task activity information includes an activity by date linked with the visit date included in the task information 111,
The schedule management module 220 may be configured to receive the clinical trial task output from the task activity information mapped to the task information 111 related to the requested clinical trial task through the input / And the date-specific activities are further output in a calendar form according to a predetermined method.
Clinical trial data management system.
3. The method of claim 2,
The task information 111 further includes contact person information set for each activity by date,
The schedule management module 220 may request the output of the clinical trial task through the input and output unit 310 by inputting the representative information included in the task information 111 related to the requested clinical trial task, And the visit date associated with the activity is output.
Clinical trial data management system.
The method of claim 3,
Wherein the assignment activity information includes an agreement acquisition activity for the subject, a screening activity for the subject, and a monitoring activity for the subject.
Clinical trial data management system.
delete delete The method according to claim 1,
The clinical trial data management system further includes a material database (150) in which material information is stored,
Wherein the material information is mapped to the task information (111) by the input / output unit (310) and stored in the material database (150)
Clinical trial data management system.
8. The method of claim 7,
The task information 111 further includes target subject information input by the input / output unit 310,
The quotation management module 210 outputs the target number of subjects information included in the task information 111 related to the requested clinical trial task through the input / output unit 310 when requesting the output of the clinical trial task Or the target number of subjects included in the target number of subjects information for a predetermined period of time,
Clinical trial data management system.
9. The method of claim 8,
The task information 111 further includes information on the number of currently performed subjects input by the input / output unit 310,
The quote management module 210 outputs the information on the number of currently performed subjects contained in the task information 111 related to the requested clinical trial task through the input / output unit 310 Or cumulatively outputs the number of currently performed subjects included in the current number of subjects to be performed for a preset period of time.
Clinical trial data management system.
10. The method of claim 9,
The task information 111 further includes a task tracking list input by the input / output unit 310,
The quotation management module 210 further outputs the task tracking list included in the task information 111 related to the requested clinical trial task through the input / output unit 310 when requesting the output of the clinical trial task ≪ / RTI >
Clinical trial data management system.
delete 11. The method of claim 10,
The clinical trial data management system further comprises a protocol setting module 230,
The quotation management module 210,
Output unit 310, stores the visit date of the subject inputted through the input / output unit 310 in the subject's activity information,
The protocol setting module 230 calculates an error between the visit date of the subject inputted through the input / output unit 310 and the visit date of the subject according to the subject visit plan included in the subject activity information, It is determined whether or not it belongs to the error range,
The schedule management module 220 may be configured such that when the output of the clinical trial task is requested through the input / output unit 310, the visit date of the subject included in the task information 111 related to the requested clinical trial task And outputting in the form of a calendar according to a predetermined method whether or not it falls within the error range of the plan.
Clinical trial data management system.
delete 13. The method of claim 12,
Wherein the subject activity information includes a subject test appointment date,
The protocol setting module 230,
Output unit (310), and whether or not the testee inspection reservation date included in the subject's activity information is coincident with the testee's visit date entered through the input / output unit (310)
Clinical trial data management system.
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